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Replacement intervals for high-efficiency filters in pharmaceutical plant air conditioners

Replacement intervals for high-efficiency filters in pharmaceutical plant air conditioners

In the pharmaceutical industry, air conditioning high-efficiency filters are used as filters for the treatment and filtration of air in the production space, aseptic production is mandatory for the use of high-efficiency filters, and the advantages of solid and semi-solid dosage form production will also be used, H13 and H14 are two types of high-efficiency filters with filtration efficiencies, and the latter has a retention rate of 99.995%. How often do high-efficiency filters need to be changed in a pharmaceutical plant?

Air conditioning high-efficiency filters generally need to be replaced every 1-2 years to ensure the purification effect, some require annual replacement of high-efficiency filters, regardless of the test results, which is reasonable. According to the relevant GMP guidelines, there is no specific data on the period that a high-efficiency filter can be used. According to GMP requirements, HEPA filters must not have leakage, which needs to be confirmed and regularly performed by leakage testing, which is a must for aseptic workshops.

Of course, integrity is not the only thing that matters with HEPA filters. The loading of the filter and the differential pressure upstream and downstream are also important. If the differential pressure above and below the filter rises, the energy demand of the supply and exhaust system increases so that the necessary number of air changes can be maintained. To protect the HEPA filter, the pre-filter is usually a fine filter like the F7 and F9 medium efficiency filters. The pre-filter needs to be changed regularly to protect the HEPA filter from clogging.